IMPACT OF FORMULATION PARAMETERS ON FAST DISSOLVING TABLET OF ONDANSETRON HYDROCHLORIDE PREPARED BY PRESSURIZED HOMOGENIZATION TECHNIQUE
Sachin S Salunkhe*, Neela M Bhatia, Prathamesh A Kulkarni, Apurva S Kale,Unmesh E Pagar, Manish S Bhatia
ABSTRACT
The demand for fast dissolving tablets of OndansetronHCl has been
growing during the last decade especially for the geriatric and pediatric
patients. OndansetronHCl is a recognized as antiemetic drug, so
development of an FDT OndansetronHCl and to evaluate the effect of
various concentrations of superdisintegrant and binder on its
disintegration time and release profile was the prime objective of this
research work. Methods: Tablets were prepared by high pressure
homogenization followed by direct compression.22 factorial design
was applied in which concentration of superdisintegrant and binder
were taken as independentvariables and disintegration time and
percentage release were taken as dependent variables. The prepared
tablets wereevaluated for weight variation, hardness, friability,
disintegration time, content uniformity, and % drug release. Direct
compression process was selected for this formulation of ODT tablets,
because porous nature is more in direct compression blend than wet granulation blend, so
tablet will facilitates for faster disintegration and dissolution. Results: The optimised batch of
fast dissolving tablet of Ondansetron hydrochloride prepared by pressurized homogenization using taste masking polymer Eudragit E-100 complies for all evaluation tests as per Indian
Pharmacopoeia and applied statistical design was found to be significant.
Conclusions: It was concluded that pressurized homogenization technique is a useful method
forpreparing fast dissolving tablets of ondansetron followed by direct compression.
Keywords: Fast dissolving tablets; superdisintegrants; ondansetron; direct compression; factorial design.
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